Geriatric Medicine, Helsingborg Hospital, Charlotte Yhléns Gata 10, 251 87, Helsingborg, Sweden.
Clinical Sciences, Lund University, Lund, Sweden.
Aging Clin Exp Res. 2022 Dec;34(12):3115-3121. doi: 10.1007/s40520-022-02263-0. Epub 2022 Oct 15.
Research involving multimorbid older patients is gaining momentum. However, little is known about how to plan a randomised controlled trial (RCT) involving this group of patients. An evidence-based approach to the challenges of a recruitment process could guide researchers and help prevent underpowered trials.
To define the number of multimorbid older patients that need to be identified and the number of eligible patients that need to be invited to achieve the desired recruitment number to a RCT.
We used recruitment data from the GerMoT trial, a RCT comparing proactive outpatient care based on Comprehensive Geriatric Assessment with usual care. Multimorbid older patients with high healthcare utilisation were recruited to the trial.
Of the 1212 patients identified in a database as meeting the inclusion criteria 838 (70%) could be invited to participate in the trial. The rest could not be invited for a variety of reasons; 162 had moved out of area or into nursing homes and 86 had died before they could be contacted. 113 could not be reached. 450 (54%) of the invited patients agreed to participate.
In our study, we have shown that it is possible to achieve a good consent rate despite older participants with multimorbidity. This can be used when planning an RCT for this patient group, who are often excluded from clinical trials. Our results are specific to a context that provides similar abilities to identify and recruit patients as can be seen in Sweden.
涉及多病共存的老年患者的研究正在兴起。然而,对于如何为这组患者设计一项随机对照试验(RCT),人们知之甚少。采用循证方法解决招募过程中的挑战可以为研究人员提供指导,并有助于防止低效能试验。
确定需要识别的多病共存老年患者数量以及需要邀请的合格患者数量,以达到 RCT 的预期招募数量。
我们使用了 GerMoT 试验的招募数据,该试验比较了基于综合老年评估的主动门诊护理与常规护理。试验招募了高医疗保健利用率的多病共存老年患者。
在数据库中确定的符合纳入标准的 1212 名患者中,有 838 名(70%)可以邀请参加试验。其余的患者由于各种原因无法邀请参加;162 人已搬离该地区或入住疗养院,86 人在联系他们之前已去世。113 人无法联系到。450 名(54%)受邀患者同意参加。
在我们的研究中,尽管参与者患有多种疾病且年龄较大,但我们已经证明可以获得较高的同意率。这可用于计划此类患者群体的 RCT,这些患者通常被排除在临床试验之外。我们的结果特定于一个可以识别和招募患者的环境,就像在瑞典看到的那样。